ZADITOR- ketotifen fumarate solution

Zaditor by

Drug Labeling and Warnings

Zaditor by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - ACTIVE INGREDIENT SECTION

Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)

OTC - PURPOSE SECTION

Antihistamine

INDICATIONS & USAGE SECTION

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

WARNINGS SECTION

For external use only

Do Not Use

• if solution changes color or becomes cloudy
• if you are sensitive to any ingredient in this product
• to treat contact lens related irritation

WHEN USING THIS PRODUCT

• do not touch tip of container to any surface to avoid contamination

• remove contact lenses before use

• wait at least 10 minutes before reinserting contact lenses after use

• replace cap after each use

STOP USE AND ASK A DOCTOR IF YOU EXPERIENCE ANY OF THE FOLLOWING

• eye pain
• changes in vision
• redness of the eye
• itching worsens or lasts for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

• Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.
• Children under 3 years of age: Consult a doctor

OTHER INFORMATION

• Only for use in the eye.
• Store between 4°-25°C (39°-77°F).

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01%, glycerol, purified water, sodium hydroxide and/or hydrochloric acid

HOW SUPPLIED

Product: 50090-1037

NDC: 50090-1037-0 5 mL in a BOTTLE, DROPPER

QUESTIONS?

call toll-free
1-800-757-9195
MedInfo@AlconLabs.com
www.zaditor.com
Serious side effects associated with use of this product may be reported to this number.

ketotifen fumarate

INGREDIENTS AND APPEARANCE

ZADITOR  
ketotifen fumarate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-1037(NDC:0065-4011)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G)	KETOTIFEN	.35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Glycerin (UNII: PDC6A3C0OX)
Sodium Hydroxide (UNII: 55X04QC32I)
Hydrochloric Acid (UNII: QTT17582CB)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-1037-0	1 in 1 CARTON	11/28/2014
1		5 mL in 1 BOTTLE, DROPPER ; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077200	12/21/2012

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-1037)